Group Quality Management System Manager
il y a 4 semaines
We are EssilorLuxottica, a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. Our company brings together the complementary expertise of two industry pioneers to create a vertically integrated business that addresses the world's evolving vision needs and the global demand of a growing eyewear industry.
With over 180,000 dedicated employees in 150 countries, our people are creative, entrepreneurial, and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to "see more and be more" thanks to our innovative designs and lens technologies, exceptional quality, and cutting-edge processing methods. Every day, we impact the lives of millions by changing the way people see the world.
Job Responsibilities:- Develop and maintain the Group Ophthalmic Lens Quality System in accordance with applicable medical device regulations, standards, and best practices.
- Maintain the compliance of the group QMS and continuously adjust it to external regulatory evolutions and internal business needs.
- Support the quality certification process of Legal Manufacturers and Manufacturing sites from a global QMS perspective.
- Develop and manage a worldwide network to maintain and improve the Group QMS.
- Participate in the Group Internal Auditor pool and contribute to the qualification of Internal Auditors.
- Support external inspections, including Certified Bodies, Notified Bodies, and Health Authorities.
- Deploy and maintain quality documentation systems within the group.
- Companies: All entities linked to EssilorLuxottica Group for Ophthalmic Lenses business.
- Regulations and Standards: Medical devices, active wearable devices, ISO 13 485, MDR, 21 CFR Part 820(FDA).
- This context will evolve with EssilorLuxottica Group structure.
- Holds a diploma in Engineering, Biology, Pharmacy, or Quality.
- Experience in Quality system management or design of new systems in medical device fields.
- Previous exposure to a multinational/global scope is a must, along with good knowledge of regulations: ISO 13 485, MDR, 21 CFR Part 820(FDA).
- Excellent technical writing skills in English are a must (able to map processes and create comprehensive yet accurate process and procedures). French and/or Italian are a plus.
- Initiative and autonomy in a cross-functional position in an international Group.
- Self-development capacity.
- Communication and influence skills at multiple levels: from top management to operators.
- Extended experience with Quality.
- Transversal network management & Team Building.
- Capacity to transfer knowledge.
- Good interpersonal skills and business focus.
- Knowledge of ophthalmic industry is a plus.
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